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FDA 510(k)

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

K-Number: K080109 · 2008-03-20

ApplicantSynthes (Usa)
Decision Date2008-03-20
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K080109. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) MODULAR BLADE PLATE SYSTEM?

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Synthes (Usa). The 510(k) number is K080109.

When did SYNTHES (USA) MODULAR BLADE PLATE SYSTEM receive FDA 510(k) clearance?

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM received FDA 510(k) clearance on 2008-03-20, under 510(k) number K080109.

Who is the listed applicant for SYNTHES (USA) MODULAR BLADE PLATE SYSTEM?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES (USA) MODULAR BLADE PLATE SYSTEM?

The FDA product code for SYNTHES (USA) MODULAR BLADE PLATE SYSTEM is KTW.

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Other records listing Synthes (Usa) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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Related Devices (Code: KTW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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